Clinical Strategy & Operations Director

Position Overview:
Outset is looking for a knowledgeable and passionate individual to lead our clinical affairs and operations efforts. Reporting to the Medical Officer, this role is responsible for determining and developing the clinical evidence required to support the use of Tablo across a range of clinical settings. The individual will work cross functionally with the commercial and product development teams, company clinical advisors and key opinion leaders in the market to develop evidence on clinical outcomes, improved user experience and reduced cost associated with adoption of Tablo.
The ideal candidate should be well versed in clinical research for medical devices in both the pre-market and post-market spaces, be naturally curious and a creative problem solver. He or she should be able to lead a diverse group and able to develop and deliver a clinical evidence plan with both internal and external stakeholders. Finally, he or she should be passionate about serving customer needs through innovative technology applications and want to be a part of creating a paradigm shift in renal replacement therapy.
Core Responsibilities:

Develops and implements clinical strategy insupport of Outset’s business objectives;including resourcing and timelines
Manages clinical affairs organization includingcareer development and regular 1x1s; drivesteam towards the achievement of strategicpriorities
Oversees the conduct of clinical trials to ensurecompliance and alignment with overall strategy
Collaborates extensively with MA to executepublication pipeline and regulatory to supportexpanded indications and claims

Essential Job Functions and Responsibilities:
Program Management

Develops clinical strategy and builds capabilities,resources, and processes for execution
Expands clinical program to meet the growingneeds of the organization
Directly and indirectly oversees clinical trials toensure compliance, accuracy, and alignment withbusiness objectives
Proactively collaborates with MKTG, regulatory andMA teams to ensure alignment around claims andpublications

Clinical Strategy

Develop and manage the overall clinical evidence and publication strategy for the organization
Drive and manage FDA submissions and communications
Establish and approve of clinical design and implementation of clinical protocols, data collection systems, and final reports in both the pre-market and post-market spaces
Identify appropriate investigators or study sites and support negotiation of clinical trial agreements, manage program budgets, and monitor adherence to protocols
Interface with investigational sites, clinical consultants, Contract Research Organization, and other vendors

People Management

Supports and coaches clinical affairs team memberson career development; develops team for futuregrowth within the organization
Leads directly and indirectly across the organization
Fosters integration and collaboration across teams
Successfully and strategically prioritizes programsand initiatives

Stakeholder Relationship Management

Manages stakeholder relationships serving as point-of-contact clinical trial escalations and issues
Oversees overall program timelines and associatedrelationships
Manages internal and external stakeholderrelationships as the key clinical affairs contact forOutset

Partner cross-functionally with marketing, medical affairs, product development, sales, regulatory and other parts of the organization as needed to define the key clinical requirements, and developing execution plans

Required Qualifications:

B.S. in engineering or life sciences, advanced degree (M.S., M.D., or PhD.) preferred
Minimum of 8 years of progressive leadership experience across the design, management and evaluation of clinical studies and evidence development strategies
Ability to gain and share knowledge regarding changing therapeutic areas. Extensive and varied clinical and laboratory research experience. Experiencing working with advanced research groups and product management on incorporating new technologies into product pipeline.
Communicates clearly and effectively both orally and in writing with persons having diverse backgrounds of knowledge and experience; conduct meetings and make professional presentations; teach complex concepts and explain clinical material to non-clinical users

Desired Qualifications:

Extensive knowledge of US FDA CFR and guidelines applicable to conducting clinical trials (i.e., GCP certification or similar). Strong knowledge of protocol and device development processes, clinical study design, study planning and management, and data monitoring.
Extensive knowledge of EU MDR submission and document preparation, including the technical file, dossier for CE marking and other requirements.
Project management and budgeting skills enabling efficient planning and execution of program milestones.
Successful track record of hiring, developing, and managing high quality team members.
Team player who can use positive methods to motivate his/her team and build good working relationships with cross-functional teams.
Good organizational skills and ability to meet tight deadlines in an environment of competing priorities. Ability to routinely work on multiple tasks with multiple people while effectively prioritizing.
Excellent interpersonal skills including problem recognition and solution definition with strong attention to detail, accuracy, and organization.
Ability to create, implement and evaluate operational and administrative processes.
Consulting and/or multi-disciplinary experience preferred.
Ability to travel up to 30% (US)

The Annual Salary range for this position is: $185,000-240,000 plus bonus and stock.
We feel passionately about pay equality. Discretionary adjustments to the position’s starting compensation may be made in consideration of other relevant factors pertaining to eligible applicants, including, but not limited to, their specific skills, level, geographical location, and comparison to other employees already in the same or similar roles.
*This range represents our good-faith and reasonable estimate regarding what we reasonably expect to pay for this position at the time of posting.
Outset also offers the following benefits:

EAP/Mental Health
Life Insurance/AD&D
Short/Long Term Disability
FSA (Dependent & Healthcare)
HSA w/ Employer contribution
Commuter Benefits
401K w/ company match
Fertility benefits
Wellness initiatives
Legal Assistance
Pet insurance
Financial Advisement & Wellbeing
Tuition Reimbursement
Student Loan Payback
Employee discounts
Professional Development/Learning
Collaboration Days (lunch onsite)
Happy Hours/Karaoke
PTO/Sick time
Holidays + Volunteer Day

Privacy is important to us. Please review ourApplicant Privacy Notice.
Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

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